A Medical Device Daily

AnazaoHealth (Tampa, Florida) said that a patent will be issued to the company for a Stabilized and Lyophilized Radiopharmaceutical Agent. The invention being patented relates to the method of preparation and stabilization of a diagnostic or therapeutic radiopharmaceutical useful in mammalian imaging and cancer detection and resulting composition.

The invention is a method of preparation of radioactive diagnostic radiopharmaceutical in a stable, shippable, lyophilized form by an apparatus designed to rapidly flash freeze and dehydrate a radiopharmaceutical composition to minimize radiolysis.

Robert McKenzie, senior VP, brachytherapy and nuclear products for AnazaoHealth, said, “The novelty in the invention is centered on the rapid cooling and removal of ambient vapor and then ultra-cold removal of ambient vapor when the potential of explosive liquid oxygen is eliminated. The radiopharmaceutical requires no further cold or refrigerated storage subsequent to stabilization, and can be delivered nationally overnight.”

In other patent news: Fujirebio Diagnostics (Malvern, Pennsylvania), a cancer diagnostics company, said that it has received notification of allowance for the first of a family of patents for its HE4 biomarker.

Covering the measurement of HE4 and antibodies to HE4 in blood, serum and plasma, the patent will allow Fujirebio to develop the biomarker for detecting, monitoring and prognosis of ovarian cancer. The patent includes claims in which HE4 is used in conjunction with other ovarian cancer markers such as Fujirebio’s CA 125, the industry’s current gold standard for monitoring ovarian cancer.

Fujirebio said it plans to seek FDA regulatory clearance of the HE4 test later this year.

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